Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Frequency (Percentage) of Participants With Adverse Drug Reactions [ Time Frame: Up to 104 weeks from first administration of study drug ]

Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".

Original Primary Outcome Measures (submitted: December 12, 2011)

Incidences of adverse drug reactions [ Time Frame: up to 104 weeks ]

Serious adverse events [ Time Frame: up to 104 weeks ]

Incidence of the following adverse events of special interest - Haemorrhage and bleeding - Myocardial infarction - Gastrointestinal disorder [ Time Frame: up to 104 weeks ]

Incidences of Stroke and Systemic Embolism (SEE) [ Time Frame: Up to 104 weeks from first administration of study drug ]

Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.

Original Secondary Outcome Measures

Not Provided

Current Other Outcome Measures

Not Provided

Original Other Outcome Measures

Not Provided

Descriptive Information

Brief Title

Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

Official Title

Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation

Brief Summary

To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).